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NCT05250973 · ClinicalTrials.gov registry record · Phase 2

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

A Phase 2 study of Amyloidosis, sponsored by Janssen Research & Development.

Active
Registry status
Phase 2
Development phase
151
Enrollment target
20
Study locations

NCT05250973 is a Phase 2 study of Amyloidosis that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 151 participants, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05250973, a Phase 2 study of Amyloidosis, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
151 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

Conditions Studied

Amyloidosis

Interventions

  • DRUG Cyclophosphamide
  • DRUG Dexamethasone
  • DRUG Daratumumab
  • DRUG Bortezomib

Study Locations (20)

Massachusetts

  • Tufts Medical Center - Boston
  • Boston University Medical Center - Boston

North Carolina

  • Levine Cancer Institute - Charlotte
  • Wake Forest University - Baptist Medical Center - Winston-Salem

Ohio

  • University Hospital of Cleveland - Cleveland
  • Ohio Health Research Institute - Columbus

Alberta

  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute - Edmonton

California

  • City of Hope - Duarte

Connecticut

  • Smilow Cancer Hospital/Yale Cancer Center - New Haven

Florida

  • Moffitt Cancer Center - Tampa

Georgia

  • Winship Cancer Institute Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2022-03-01
Est. Completion 2027-03-02
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05250973

The ClinicalTrials.gov registry entry for NCT05250973 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amyloidosis appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT05250973 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Massachusetts, North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT05250973 about?

NCT05250973 is a clinical study titled "A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis". The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis...

What is the current status of trial NCT05250973?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2022-03-01. Estimated completion is 2027-03-02.

What conditions does trial NCT05250973 study?

This clinical trial studies the following conditions: Amyloidosis.

What interventions are being tested in trial NCT05250973?

The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT05250973?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05250973 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.